Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA ISSUES WARNING LETTER TO DIVERSIFIED MANUFACTURING

The FDA has issued a warning letter to Minnesota-based
OTC drugmaker Diversified Manufacturing, accusing the company of violating current
good manufacturing practices (cGMPs).

The agency conducted an inspection of the firm's Newport, Minn., manufacturing
facility in March, during which time the FDA's investigators found "significant
deviations from cGMP regulations," according to the letter, which was posted
to the FDA's website. Among the major violations:

Failure to validate cleaning of the equipment and to maintain records of maintenance,
cleaning, sanitizing and inspection of the equipment. The FDA found no assurance
that Diversified's mixing vessels used for industrial chemicals were not also
used in the production of drugs because the mixing vessels were not dedicated
and cleaning records were not maintained.

Failure to have, for each batch of drug product, appropriate laboratory determination
of satisfactory conformance to final specifications for the drug product, prior
to release. The inspection revealed finished drug products were never tested
for identity and strength prior to their release and distribution.

Failure to withhold from use each lot of components, drug product containers
and closures until the lot has been sampled, tested, examined and released by
the quality control unit. Diversified did not complete any raw material testing
for any materials received, the FDA said, adding the company did not conduct
a specific identity test on components and had also not verified its supplier's
Certificate of Analysis.